Clinical Trial: P53 Gene Combined With Radio- and Chemo-therapy in Treatment of Unresectable Locally Advanced Head and Neck Cancer

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Recombinant Adenoviral Human p53 Gene Combined With Radio- and Chemo-therapy in Treatment of Unresectable, Locally Advanced Head and Neck Cancer - a Open-labeled Randomize

Brief Summary: The objectives of this study are to investigate the efficacy and safety of rAd-p53 gene combined with radio- and chemo-therapy vs. radio- and chemo- therapy only in treatment of unresectable, locally advanced head and neck cancer. This is a phase 2, open labeled, and active-controlled study.

Detailed Summary: To evaluate benefits of rAd-p53) gene therapy combined with radio- and chemo-therapy in treatment of unresectable, locally advanced head and neck cancer, total of 60 patients with above condition will be randomly assigned to two groups: the experiment group (EG) and the control group (CG). The EG received multi-point injections of rAd-p53 into tumor on day 1, 8 and 15 at a dose of 2 × 10^12 viral particles (VP) in a 21-days cycle. Both EG and CG were given radiotherapy at a total dose of 60 Gy and chemotherapy (Cisplatin 100 mg/m2 IV on days 1 plus paclitaxel 30 mg/m2 IV on day 1, 8 and 15). The patients will be treated until disease progression, withdrawal from study, or untolerated adverse events. study endpoints are efficacy (Progression-free survival, overall survival) and safety variables.
Sponsor: Shenzhen SiBiono GeneTech Co.,Ltd

Current Primary Outcome: progression-free survival [ Time Frame: three years after starting treatment ]

Patients will be followed up until progression or death, withdrawal from study, or until data cut-off after 3 years.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Adverse events [ Time Frame: from starting study treatment until 30 days after the last study treatment ]
    Adverse events
  • overall survival [ Time Frame: three years after starting study treatment ]
    Patients will be followed up until death, withdrawal from study, or until data cut-off after 3 years.


Original Secondary Outcome: Same as current

Information By: Shenzhen SiBiono GeneTech Co.,Ltd

Dates:
Date Received: April 20, 2015
Date Started: May 2015
Date Completion: December 2018
Last Updated: April 23, 2015
Last Verified: March 2015